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SC efgartigimod PDUFA date pushed back to June 20, 2023
https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/90072505/argenx-receives-notification-of-pdufa-date-extensi
Amsterdam, the Netherlands — argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the Biologics License Application (BLA) for subcutaneous (SC) efgartigimod (1000mg efgartigimod-PH20) for the treatment of adult patients with generalized myasthenia gravis (gMG) to June 20, 2023.
The FDA notified argenx on January 26, 2023 that information submitted in connection with the ongoing review of the SC efgartigimod BLA constituted a major amendment and requires an extension to allow sufficient time to review. No additional data or studies have been requested at this time.
“We are confident in the profile of SC efgartigimod and the strength of the ADAPT-SC dataset showing noninferiority of our subcutaneous product to VYVGART®. We will continue to work closely with the FDA as it completes its review to bring this important medicine to people living with gMG," said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx.
What was the news? I haven't seen it. TIA!
Another big options bet today on Feb 30's. Over 6 thousand contracts at $4 a pop. Similar volume for April 30s and April 40s.
Thanks for that Roche tidbit. Of course, HALO's crack PR team has it at phase 1.
https://halozyme.com/drug-delivery-technologies/enhanze/#pipeline_group_1
Yes, that was the one I was referencing that raised eyebrows, but seems like he was alone in that regard. Probably wanted to buy his girlfriend a nice gift for Xmas.
No, you're reading it correctly, however the sales were mostly to cover tax obligations, and these are stated in a little footnote right in the Form 4. There were one or two farily significant sales by a director that were more of the type to raise eyebrows, but not enough to establish a trend, in my opinion at least.
All the best,
-Fritz
With a few exceptions, management has generally held on to their HALO stock, so I don't agree that that is an issue here.
Helen was not on her game at this presentation. The one positive I took out of it was the three new deals. I'm not her biggest fan, but when she says things like that they usually become reality. The only question is how large the deals will be or, if moderate in scale, will they represent a new and impactful class of collaboration. Stay tuned.
In your estimation, why did they chose to force the debt into equity? Is there a strategic purpose? They had been paying a very favorable interest rate (1.5% if I recall correctly).
Today's drop was a combination of three things, IMHO:
a) technical factors, which I spoke about a few times in the last few weeks,
along with the precipitating events of the
b) change in guidance
as well as
c) the dilution.
In her presentation, Helen all but promised 3 new deals this year. One Enhanze deal, one enhanze plus high volume injector, and one small volume injector deal. If she can get them done, and if they're not small potatoes, it might help regain lost momentum.
Issuing shares at the conversion price of $23.79 and buying at $50, more fun with spinning wheels and financial engineering.
Meanwhile, Helen contunues to fail to deliver the goods but is good at creating these distractions....
SVP Leerink reiterated their outperform rating with a PT of $61, but that was 4 hours before the announcement of the calling in of the convertible debt.
Getting hit AH
Thanks. EOM
Not questioning the thesis, but he actually does say that repeatedly. And why not? It's a part of their business model. Do you think an acqusition (by anybody) is imminent now that the smoke has cleared to a large degree? (Imminent defined as next Q or 2).
Yes, but he literally says that every time he's asked. LOL!
I really don't have a feel for all of the various dynamics at play, including time frame.
Dew, in your estimation, what are the odds of RVNC being bought out vs. charting a solo path?
TIA, and Happy New Year!
All the best,
-Fritz
Argenx updates on SC efgartigimod
https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/89930889/argenx-highlights-2023-strategic-priorities-across
Reach More Patients with VYVGART
argenx is planning for multi-dimensional expansion to reach more patients with VYVGART, its first-in-class neonatal Fc receptor blocker. This includes generalized myasthenia gravis (gMG) patients through regulatory approvals in new regions and the launch of its subcutaneous (SC) product offering, as well as a new autoimmune indication with the VYVGART regulatory submission for ITP in Japan.
Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2023, for U.S. Food and Drug Administration approval decision on SC efgartigimod for gMG
Regulatory approval decision on SC efgartigimod for gMG expected in EU in fourth quarter of 2023
Submission for marketing approval of SC efgartigimod for gMG expected in Japan in first quarter of 2023
Regulatory approval decisions of VYVGART for gMG expected in Canada in third quarter of 2023 and in China and Israel by end of 2023
gMG launch in France, United Kingdom and Italy expected by year-end 2023 following review of respective reimbursement dossiers
Submission for Japan marketing approval of VYVGART for ITP expected in mid-2023
Everybody knows that there are dozens, if not hundreds, of IV drugs that could be co-formulated with enhanze, yet the pace of these deals is perplexingly glacial. Any ideas why?
Agree about the useless computer generated stuff put out by that "research" site. Disagree about a significant bounce, at least for now.
My feeling is that we get back to the $40s and see a period of consolidation maybe in the low $50s. Another run is not imminent unless triggered by a news event.
As I mentined about a month ago, my opinion is that HALO is fullly valued at the mid $50s and I thought that the run to near $60 was overblown. I said a pullback to $55 was a near certainty and here we are. I did have my trading shares called away and I've elected to put those profits into another more promising investment. I continue to hold my core HALO shares and will constantly reassess that position as the year moves along. A market downdraft and a long stagnant period with no percieved progress could result in this stock reaching the 200 day which today is about $46. On the other hand, a good stretch of new deal announcements and we could be on our way to the next level. Time will tell.
Happy and healthy New Year to all who post and lurk here. My best to you and your loved ones.
-Fritz
It doesn't take much to feed their insanity.
Wondering what concrete things your theory is based on?
Thanks, -Fritz
Thanks for sharing that.
Just saw that. Would love to read these notes to get their take. I guess we can put aside the worry about downgrades fo now. LOL!
Fascinatng look into the industry. Thanks for sharing.
-Fritz
The operative word was "guessing". LOL
Interesting, I wonder what new scam they are cooking up this time.
Friday is expiry day so I'm guessing it's just partially rolling out to future dates and partially just ordinary hedging of new positions by the pros.
I appreciate your final point about the limitations Horizon may have had in terms of resources, and how Amgen might be able to fund the necessary trials. That may prove to be the key, but, as you say, only time will tell.
The Tepezza deal with Horizon goes back two years ago to December 2020 and according to Halozyme's web site it has not gotten past phase 1.
What is not clear to me is how Amgen's acquisition will change the dynamic. Unless I'm mistaken, Amgen has not entered into any deal with Halozyme, so I wonder what their commitment is to Enhanze subcu formulation. Horizon has not been in a particular hurry and Amgen has shown no interest, so I'm skeptical that Amgen/Horizon is a meaningful transaction for Halozyme.
https://www.fiercepharma.com/drug-delivery/horizon-pays-halozyme-190m-to-develop-subq-thyroid-eye-disease-med
https://halozyme.com/enhanze/#pipeline_group_1
How is that relevant here?
Right, looks like he sold about a quarter of his holdings. That's a little surprising.
Do you know when and how this litigation was brought to light?
The patent rolloff for enhanze is not far off but there is a potential lengthening of patent protection both in the US as well as Europe due to the argument that the co-formulation represents a new drug and therefore a new patent, or at least an extension, should be granted. This is being challenged in the courts and, if HALO loses, their income estimate might well be adversely affected. This topic has been a major source of confusion for a long time.
That is a major uncertainty.
This was a surprising week (for me at least) and it ended on a high note Friday with some decent volume, which had been missing, and end of day trades were at the highs. It might have a little more to run. Absent news I'm also expecting a retracement which could, in time, dip to about $47 or so, but that is assuming another long period of inactivity on the new deals front and the addition of other market downdrafts, both of which are probable. A near term retrace back to the mid $50s is almost inevitable, but I've no idea as to the exact timing there.
Things are moving along and your summary is perfectly on target; the one thing I'm not certain of is the pricing model used to get to that $69. How would you formulate that? How do you see the current pps given the earnings reported?
Looking at the chart, I think there is a good chance you'll have your order filled.